Brand Name | PERMACOL |
Type of Device | MESH, SURGICAL |
Manufacturer (Section D) |
TISSUE SCIENCE LABORATORIES |
victoria house, victoria road |
aldershot, hampshire GU11 1EJ |
GB GU11 1EJ |
|
Manufacturer (Section G) |
TISSUE SCIENCE LABORATORIES |
victoria house, victoria road |
|
aldershot, hampshire GU11 1EJ |
GB
GU11 1EJ
|
|
Manufacturer Contact |
lisa
hernandez
|
60 middletown ave. |
north haven, CT 06473
|
2034925563
|
|
MDR Report Key | 10565417 |
MDR Text Key | 207894532 |
Report Number | 9617613-2020-00075 |
Device Sequence Number | 1 |
Product Code |
FTM
|
UDI-Device Identifier | 10884523000191 |
UDI-Public | 10884523000191 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K120605 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
09/22/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2013 |
Device Model Number | P151828 |
Device Catalogue Number | P151828 |
Device Lot Number | 10B0308 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/02/2020 |
Initial Date FDA Received | 09/22/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | P151828 PERMACOL 18X28X1.50 X1 (LOT#10B0308) |
Patient Outcome(s) |
Required Intervention;
|
|
|